NCT07340229

Brief Summary

This randomized controlled trial examined the effects of laughter yoga on resilience and coping attitudes in mothers of children hospitalized in the pediatric intensive care unit. Mothers whose children had been hospitalized for at least one week were randomly assigned to an intervention or control group. The intervention group participated in structured laughter yoga sessions lasting 15-20 minutes over 3-4 days, while the control group received routine care. Psychological resilience and coping attitudes were assessed using standardized measurement tools. The study aimed to provide evidence for a brief, non-pharmacological intervention to support maternal psychological well-being in PICU settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 2, 2026

Last Update Submit

January 12, 2026

Conditions

Keywords

Pediatric Intensive Care UnitResilienceCoping SkillsFamily Centered NursingLaughter TherapyLaughter

Outcome Measures

Primary Outcomes (2)

  • Connor-Davidson Resilience Scale

    The Connor-Davidson Resilience Scale (CD-RISC-10) was originally developed by Connor and Davidson (2003), subsequently shortened to 10 items by Campbell-Sills and Stein (2007), and adapted to Turkish by Sarıçam (2010). The scale is scored using a five-point Likert-type format (0-4), with higher total scores indicating greater resilience. In the Turkish validity and reliability study, the scale was reported to have a single-factor structure with a Cronbach's alpha coefficient of 0.81. In the present study, Cronbach's alpha coefficients were 0.79 for the pre-test and 0.80 for the post-test.

    Six months

  • Coping Attitudes Assessment Scale

    The scale was originally developed by Carver et al. (1989) and adapted into Turkish by Dicle and Ersanlı (2015). The adapted version consists of 32 items and 5 subscales: Self-Help, Approach, Adaptation, Avoidance-Escape, and Self-Punishment. Items are rated on a four-point Likert-type scale, with higher total scores indicating more effective coping attitudes. In the Turkish validity and reliability study, the overall internal consistency coefficient was reported as 0.97, with Cronbach's alpha values for the subscales ranging from 0.96 to 0.99. In the present study, the overall internal consistency of the scale was 0.78 in the pre-test and 0.81 in the post-test, while Cronbach's alpha values for the subscales ranged between 0.79 and 0.82.

    six months

Study Arms (2)

Laughter Yoga Group

EXPERIMENTAL

Mothers in the intervention group participated in structured laughter yoga sessions lasting 15-20 minutes, conducted over a period of 3-4 days.

Behavioral: Laughter Yoga

Control Group

NO INTERVENTION

The control group received routine care only.

Interventions

Laughter YogaBEHAVIORAL

Mothers in the intervention group participated in structured laughter yoga sessions lasting 15-20 minutes, conducted over a period of 3-4 days.

Laughter Yoga Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers aged 18 years or older
  • Ability to read and speak Turkish
  • Having a child hospitalized in the pediatric intensive care unit (PICU) for at least one week
  • Access to basic communication tools (telephone and/or internet)
  • No previous participation in laughter yoga or a similar intervention

You may not qualify if:

  • Presence of a clinically diagnosed severe psychiatric disorder
  • Having a child who was terminally ill or clinically unstable
  • Participation deemed inappropriate by the attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buca Seyfi Demirsoy Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Laughter

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A total of 40 mothers were randomly assigned to either the laughter yoga group (n = 20) or control group (n = 20).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 14, 2026

Study Start

May 1, 2025

Primary Completion

July 30, 2025

Study Completion

October 30, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations